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This document outlines the oversight and regulatory framework established by BPHC for high and maximum security laboratories, focusing on the safety and health of the public and laboratory workers. It details the permit types, review processes, oversight activities, and responsibilities of the Boston Biosafety Committee. The oversight aims to enhance public confidence in lab safety procedures through rigorous inspections, compliance assessments, and transparent reporting. The BPHC ensures adherence to regulations, promotes thorough risk management and incident reporting, and integrates community stakeholder participation.
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BPHC OversightHigh & Maximum Security Labs NIH Blue Ribbon Panel Teleconference September 09, 2008
High & Maximum Security LaboratoriesBPHC Oversight Purpose • Protect the safety and health of the public and lab workers • Increase public confidence and awareness about lab safety procedures and regulations
High & Maximum Security LaboratoriesPermitting • Permit type • Provisional • Unconditional (6) • Select agent (2) • Conditional (1) • Additional reports • More frequent inspections
High & Maximum Security LaboratoriesPermit Review Permit timelines: • BSL3 initial/renewal – 4/3 months advance • BSL4 initial/renewal – 6/4 months advance • Permit valid for 3 years • New projects – submit ≥30 days advance
High & Maximum Security LaboratoriesPermit Requirements • Required for all BSL3 & BSL4 research laboratories • Application process includes: • Document review • Biosafety/Lab safety manual • Disease surveillance plan • Evacuation and emergency response plans • Waste disposal plan • Security plan • Transportation plan • Chemical hygiene plan • Strain verification policy/procedure • Risk management program description • IBC roster • Key staff list
High & Maximum Security LaboratoriesOversight Activities • Inspections • BSL3 – one per year minimum • BSL4 – two per year minimum • Inspection components • Review of policies, procedures and documents • Staff interviews • Observation and assessment of facility and practices • Results available to public
High & Maximum Security LaboratoriesBPHC Oversight Structures • BPHC Internal • BPHC Board • BPHC Executive Director • Boston Biosafety Committee (BBC) • BPHC Staff – Biosafety Program Director; General Council • External • City of Boston • City Working Group • Independent consultants
High & Maximum Security LaboratoriesBPHC Oversight Structures • Boston Biosafety Committee (BBC) • At least 7 members • Appointed by BPHC Executive Director (BBC Chair) • Scientific and community representatives • 2 neighborhood residents • 1 - RDNA expertise • 3 from: public health, occupational health, infectious diseases, biosafety, environmental quality. • Other members with qualifications determined to be necessary by the ED.
High & Maximum Security LaboratoriesBPHC Oversight Structures • Boston Biosafety Committee (cont.) • Special Municipal Employee status • Conflict of interest • Gifts • Contracts • 2 year term; removal for cause; reappointment eligibility • Replaces Boston RDNA Advisory Committee • Not subject to open meeting laws
High & Maximum Security LaboratoriesBoston Biosafety Committee Duties & Responsibilities • Review effectiveness of regulations; consider changes & amendments • Provide TA/advise Board & ED • Review & recommend: • Literature & emerging science • Permit & project applications • Policies & procedures • Manuals & programs • Violations & appeals • Conduct inspections
High & Maximum Security LaboratoriesBoston Biosafety Committee Operations • Meet with sufficient frequency… • Staffed by EHO & CDC of BPHC • Notice posted on BPHC website 48 hours prior to meeting or ASAP for emergency • Minutes maintained
High & Maximum Security LaboratoriesBoston Biosafety Committee Current Status: • Applicants nominated • Applicants recruited • Representation from all required categories • High degree of expertise • Under review; appointment made by ED
High & Maximum Security LaboratoriesInstitutional Requirements • IBC for all BSL3-4 • Annual IBC report with all meeting minutes • Annual public meeting with public disclosure of research • Chair reports to RO • BPHC approves 1 community member
High & Maximum Security LaboratoriesOversight Structures • NEIDL Structures – not required by BPHC • External Scientific Advisory Committee • BPHC Representative • “… will review … for scientific merit, quality and relevance … ” • “...advise & report regularly to the EC & to the leadership of BU, to the NIAID, CDC & other agencies … on safety procedures … including verification that safety procedures are followed.” • Community Oversight Committee
High & Maximum Security LaboratoriesReporting to BPHC • Incident reporting – upon discovery, not > 24 hours • Disease Surveillance and Reporting Regulation • Mechanical or security system • Containment systems and practices • Anything reported to IBC, NIH, CDC • Executive Director informs Board and/or BBC members as deemed appropriate
High & Maximum Security LaboratoriesBPHC Enforcement • Monetary fines • Permit may be issued with conditions, revoked, suspended, modified or not renewed • Immediate closure of laboratory • Process for appeal of citation
High & Maximum Security LaboratoriesQuality & Transparency (misc.) • Annual Report to BPHC Board • Annual public meeting by BPHC • Whistleblower provisions for anonymous reporting of health and safety violations • Professional standards of best practice – City-wide drills, training, documents, etc. • Education and training
